High Precision Imaging of Prostate Specific Membrane Antigen for Personalized Treatment in Prostate Cancer

July 1, 2024 updated by: Universitaire Ziekenhuizen KU Leuven
This is an Investigator Initiated, non-commercial, single center, non-randomized, single arm, open label pilot study on 194 patients. The patients are affected by prostate cancer but in two different clinical settings. The first group is characterized by patients who are going to be operated of radical prostatectomy and they will undergo the study imaging preoperatively. The second group experiences biochemical relapse after primary treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Novel, sensitive tools, such as 68Ga-PSMA PET imaging, have great potential for very early disease detection and open the possibility of early curative local salvage treatment (with surgery, radiotherapy or a combination of both). This project will moreover provide important insights into the biodistribution and dosimetry of 68Ga-PSMA, opening possibilities of 90-Yttrium or 177-Lutetium-PSMA-based radionuclidetherapy of patients with metastatic PC in the future.

The study consists of 2 work units (WU):

Work-unit 1: Patients at high risk for nodal involvement prior to radical prostatectomy with extended lymph node dissection Work-unit 2: Biochemical recurrence after initial treatment with curative intent

Study Type

Interventional

Enrollment (Estimated)

188

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria

Work-unit 1

  • age < 75 years of age, with histologically proven invasive adenocarcinoma of the prostate
  • a risk of equal or more than 5% of lymph node metastasis (intermediate to high risk disease), according to the Briganti nomogram (1)
  • scheduled to undergo radical prostatectomy with extended lymph node dissection

Work-unit 2

  • histologically proven diagnosis of prostate cancer
  • biochemical relapse (two consecutive PSA≥0.2 ng/ml) of prostate cancer following radical local prostate treatment
  • WHO performance state 0-1
  • age > 18 years old

Exclusion criteria

Work-unit 1

  • involvement of pelvic lymph nodes assessed by multi-parametric MRI
  • evidence for bone metastasis assessed by bone scan (if PSA > 20 ng/ml)
  • WHO performance status > 2
  • previous pelvic irradiation or radical prostatectomy.
  • other malignancy except adequately treated basal cell carcinoma of the skin diagnosed during the last 5 years
  • any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

Work-unit 2

  • serum testosterone level <50ng/ml
  • symptomatic metastases
  • local relapse on MRI
  • PSA rise while on active treatment with LHRH-agonist, LHRH-antagonist, Anti-androgen, Complete androgen blockade, Oestrogen-antioestrogen therapy
  • previous treatment with cytotoxic agent for PCa
  • treatment during the past month with products known to influence PSA levels (e.g. fluconazole, finasteride, corticosteroids,…)
  • disorder precluding understanding of trial information or informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 68Ga-PSMA PET/MR
Hybrid 68Ga-PSMA PET/MR scan
Other: 68Ga-PSMA (HBED-CC) PET
68Ga-PSMA PET/MR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
68Ga-PSMA PET/MR imaging accuracy before radical prostatectomy + pelvic lymph node dissection [RP + PLND]. Work unit 1. 68Ga-PSMA PET/MR imaging accuracy in patients with biochemical recurrence after primary treatment. Work unit 2.
Time Frame: through study completion, an average of 2 year
Assessment of the sensitivity, specificity, positive and negative predictive
through study completion, an average of 2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The correlation of tracer uptake to Gleason scores within the prostate tumor and within metastatic lymph nodes. Work unit 1.
Time Frame: through study completion, an average of 2 year
Correlation between tracer uptake and pathology Gleason score
through study completion, an average of 2 year
Comparison of diagnostic accuracy between 68Ga-PSMA PET, MR and combined 68Ga-PSMA PET/MR. Work unit 2.
Time Frame: through study completion, an average of 2 year
Assessment of the sensitivity, specificity, positive and negative predictive value
through study completion, an average of 2 year
The evaluation of change in patient management based on imaging results of 68Ga-PSMA PET/MR in patients with biochemical recurrence. Work unit 2.
Time Frame: through study completion, an average of 2 year
Proportion of patients with treatments different from follow-up after the evaluation of 68Ga-PSMA PET/MRI
through study completion, an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Karolien Goffin, MD, PhD, UZ Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2017

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

July 10, 2017

First Submitted That Met QC Criteria

October 30, 2017

First Posted (Actual)

October 31, 2017

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

July 1, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S59428
  • 2016-003089-14 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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